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Companies are doing their best to accelerate experimental drugs and vaccines for COVID-19 through the pipeline. Each faces its own set of challenges, but all agree on the need for a radical rethink of the clinical development process for pandemics.
This week, Moderna Therapeutics’ modified mRNA vaccine for COVID-19 began phase 1 clinical testing. From the first description of the novel coronavirus (SARS-CoV-2) genome on 10 January, it took the company just 42 days to produce the first batches of its vaccine (mRNA-1273), which encodes a prefusion-stabilized form of the SARS-CoV-2 spike (S) protein. If it can successfully negotiate safety and efficacy testing on a larger scale, batches of the mRNA vaccine could reach clinics as early as 2021. This will be too late for the current pandemic. And given that no mRNA vaccine has ever been approved, mRNA-1273 faces numerous challenges in clinical development and manufacture before it has the possibility of being made available for global immunization.